Package 50419-325-73

Brand: gadavist

Generic: gadobutrol
NDC Package

Package Facts

Identity

Package NDC 50419-325-73
Digits Only 5041932573
Product NDC 50419-325
Description

30 mL in 1 BOTTLE, GLASS (50419-325-73)

Marketing

Marketing Status
Marketed Since 2021-02-11
Brand gadavist
Generic gadobutrol
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "355ebf0b-3a4b-428a-90c2-38aa38308f03", "openfda": {"nui": ["N0000183362", "N0000175862"], "unii": ["1BJ477IO2L"], "spl_set_id": ["b7afe34d-b70f-41a5-b89c-561bdf29f046"], "pharm_class_epc": ["Gadolinium-based Contrast Agent [EPC]"], "pharm_class_moa": ["Magnetic Resonance Contrast Activity [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 BOX (50419-325-18)  / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS", "package_ndc": "50419-325-18", "marketing_start_date": "20110315"}, {"sample": false, "description": "10 BOTTLE, GLASS in 1 BOX (50419-325-19)  / 65 mL in 1 BOTTLE, GLASS", "package_ndc": "50419-325-19", "marketing_start_date": "20110315"}, {"sample": false, "description": "30 mL in 1 BOTTLE, GLASS (50419-325-73)", "package_ndc": "50419-325-73", "marketing_start_date": "20210211"}, {"sample": false, "description": "65 mL in 1 BOTTLE, GLASS (50419-325-74)", "package_ndc": "50419-325-74", "marketing_start_date": "20210211"}], "brand_name": "Gadavist", "product_id": "50419-325_355ebf0b-3a4b-428a-90c2-38aa38308f03", "dosage_form": "INJECTION", "pharm_class": ["Gadolinium-based Contrast Agent [EPC]", "Magnetic Resonance Contrast Activity [MoA]"], "product_ndc": "50419-325", "generic_name": "gadobutrol", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gadavist", "active_ingredients": [{"name": "GADOBUTROL", "strength": "604.72 mg/mL"}], "application_number": "NDA201277", "marketing_category": "NDA", "marketing_start_date": "20110314", "listing_expiration_date": "20271231"}